Proposition 65

A brewing case spells trouble for coffee shops in California. Coffee sellers including Starbucks, Target and Whole Foods are in the midst of an ongoing lawsuit with the Council for Education and Research on Toxics (CERT) over the presence of acrylamide in coffee.

Acrylamide is on the Proposition 65 list of chemicals which California has declared are known to the state to cause cancer or reproductive toxicity. While acrylamide is not found in raw foods, the chemical can form in starchy and carbohydrate rich foods, such as potatoes, when cooked at high temperatures. Acrylamide is a natural byproduct of the coffee roasting process, and is formed when the sugars and amino acids of the coffee bean are heated.

CERT (associated with Raphael Metzger of the Metzger Law Group) is a well-known plaintiff in Prop 65 cases of this sort, and this is not the first time CERT has been involved in litigation over acrylamide in food and drink products. Acrylamide was added to the Proposition 65 list in 1990 based on studies showing it as a potential carcinogen in industrial exposures. In April 2002, a subsequent study by the Swedish National Food Administration revealed high levels of the chemical in various high carbohydrate foods which are cooked at high temperatures, including french fries, potato chips, crackers, and bread. CERT filed suit that same year against McDonalds and Burger King over the presence of acrylamide in french fries. The fast-food retailers eventually settled and agreed to post Prop 65 warnings.

Office of Environmental Health Hazard Assessment (OEHHA) has set the No Significant Risk Level (NSRL) for acrylamide at 0.2 µg/day. NSRL is the level of exposure at which chemicals on the Prop 65 list are deemed to pose no significant risk, and for which a Prop 65 warning is not required. CERT v. Starbuck Corp., et al was originally filed in 2010 against 90 coffee sellers. The suit claimed that defendants’ coffee contained 4-100x more acrylamide than the NSRL. During the first phase of a two-phase bench trial, defendants argued that the level of acrylamide in their coffee products posed no significant risk because a multitude of studies show that coffee consumption does not increase the risk of cancer. The court rejected this argument because the studies assessed the effects of coffee generally, as opposed to the presence of acrylamide in the coffee. Defendants’ argument that requiring them to post a Prop 65 warning amounts to unconstitutional forced speech was also rejected.

The second phase of the trial began in September 2017. During this bench trial, defendants argued that coffee is exempt from the NSRL standard, and rather an “alternative risk level” applies. Proposition 65 allows for a higher “alternative risk level” to apply to chemicals produced in the process of cooking foods to make them palatable or safe. Since acrylamide in coffee is naturally produced during the roasting process, Defendants argue that they are subject to this exemption.

A ruling is expected soon, and if CERT succeeds, California coffee sellers will be required to post Proposition 65 warnings. Several coffee retailers who were initially named in the lawsuit have already posted warnings in their stores. 7-Eleven, who opted to settle the suit, agreed to post warnings and pay a $900,000 fee. While Starbucks continues to challenge the suit, it has already posted warnings at its stores, presumably to limit damages it may have to pay if CERT succeeds at trial.

Conkle, Kremer & Engel attorneys will continue to monitor and report on the outcome of this case. CK&E has many years of experience advising clients about Proposition 65 and other regulatory compliance issues they face. Our attorneys help clients stay out of legal hot water by working with them to ensure their products continue to meet all legal requirements, and helping them plan for foreseeable changes in the law.

Conkle, Kremer & Engel attorneys Amanda Washton and Desiree Ho attended the Indie Beauty Expo in Los Angeles to take note of emerging trends in the beauty industry. More than 100 brands exhibited their products at this event, many of which recognized a key trend in the beauty market – consumers are becoming increasingly attentive to what is in their products and where their money is going. Countless brands touted business practices such as sharing profits with charitable causes, as well as product features like “vegan,” “natural,” and “organic.” The simpler the ingredient list, the better. The product packaging and displays reflected this gravitation towards simplicity – minimalist typography, clean lines in the artwork, and monochromatic color schemes.

As more companies hop onboard the “organic” and “natural” train, beauty brands should be careful about their advertising and labeling to avoid drawing adverse attention of regulators and others policing the market. Conkle, Kremer & Engel has published multiple blog posts throughout the years concerning “natural” and “organic” product claims. Selling “natural” products in California can be particularly hazardous without the right guidance – “natural” ingredients may be subject to Proposition 65, as CK&E has explained in the past. Manufacturers would do well to remember that the California Supreme Court has warned, particularly in claims of organic contents, “labels matter.”

With decades of beauty industry experience helping companies grow and protect their businesses, CK&E attorneys routinely guide clients through the process of complying with Proposition 65 and other complex regulatory schemes.

Can your product wrap subject you to Proposition 65 warning requirements? You bet. California has added vinylidene chloride to its long list of chemicals to which Proposition 65 applies, effective on December 29, 2017. The Office of Environmental Health Hazard Assessment (OEHHA) has not established a safe harbor level for vinylidene chloride, although that remains under consideration.

Vinylidene chloride is used in the production of polyvinylidene chloride (PVDC) copolymers. PVDC was developed by Dow Chemical Company, and was at one point used in the production of the popular food wrap product, Saran Wrap. PVDC has characteristics ideal for food packaging because it has low permeabiltiy to water vapor and gasses. While use of PVDC in Saran Wrap was later phased out due to cost and environmental concerns, other copolymers of vinylidene chloride are still commonly used in food packaging, including box overwrap, vertical form fill seal, horizontal form fill seal, and pre-made bags. Vinylidene chloride is also extensively used in a variety of other packing materials, as flame retardant coating for fiber and carpet backing and in piping, coating for steel pipes, and adhesive applications. Other common consumer products that may contain vinylidene chloride include cleaning cloths, filters, screens, tape, shower curtains, garden furniture, artificial turf, doll hair, stuffed animals, fabrics, fishnet, and shoe insoles.

Manufacturers, distributors and retailers are required to provide Prop 65 warnings to workers and consumers who are exposed to vinylidene chloride. Companies have one year from the listing date to comply with Prop 65. Companies that have not reformulated their products to remove vinylidene chloride, or that fail to provide a Proposition 65 warning on products containing it, by December 29, 2018 are at risk of receiving a “Notice of Violation” from private enforcers seeking to gain thousands of dollars in penalties and attorneys’ fees. A Notice of Violation typically precedes a lawsuit for violation of Proposition 65.

The listing of vinylidene chloride as a chemical known to cause cancer by OEHHA is a reminder that not only product contents, but also packaging materials, are included within Prop 65 compliance requirements. As we previously reported, since December 2014, products sold in California that contain diisononyl phthalate (DINP) have required a Proposition 65 warning. DINP is found is many soft plastic and vinyl products, and purported violations have been found in seemingly innocuous packaging, such as gift bags for cosmetic products.

Conkle, Kremer & Engel has many years of experience advising clients with respect to Proposition 65 and other regulatory compliance issues. CK&E attorneys help clients stay out of legal crosshairs by working with them to ensure their products continue to meet all legal requirements, and helping them plan for foreseeable changes in the law.

Sunscreen manufacturers and distributors should take note: Maui County in the state of Hawaii could become the first county in the United States to ban the sale and use of sunscreen products containing oxybenzone and octinoxate, two active ingredients approved by the U.S. Food and Drug Administration (FDA) for use in sunscreens.

In November, a Maui Hawaii County Council committee introduced and recommended for approval a bill for an ordinance that would prohibit the sale and use of sunscreen containing the ingredients oxybenzone and octinoxate. These ingredients are commonly used in commercial chemical sunscreens as protection against ultraviolet (UV) light radiation. The county-level move came after Senate Bill 1150 – introduced in 2017 by Hawaii Senator Will Espero to ban the use and application of sunscreens containing oxybenzone throughout the state of Hawaii – stalled at the end of the legislative session.

The FDA currently approves of only 16 active ingredients for use in over-the-counter (OTC) sunscreens, generally recognizing them as safe and effective. Among the ingredients are oxybenzone and octinoxate, which are commonly found in commercial sunscreen products, including from major sunscreen brands such as L’Oreal, Neutrogena and Supergoop. The European Union already imposes strict limits on the use of oxybenzone in sunscreen products as well as warning requirements.

The Maui County proposal was prompted by environmental concerns and intended to promote the health and welfare of Maui’s coral reefs and marine life. The bill’s supporters claim that oxybenzone and octinoxate have a significant impact on the marine environment, noting that both ingredients have been detected in the ocean surrounding Maui at levels that well exceed the toxicity range for coral reefs. Opponents of the ban, on the other hand, contend that the ingredients are safe for use, as they have been approved for use by the FDA.

The proposal to ban sunscreen products containing oxybenzone and oxtinoxate, other than prescription products, is now before the full Maui County Council. If approved, manufacturers, retailers and distributors of sunscreen products containing oxybenzone and oxtinoxate would have a year to ensure that their products no longer contain the banned ingredients. Businesses or persons found in violation of the law would be subject to civil penalties and administrative enforcement procedures. As of now, the bill does not contain a private right of action to allow consumers to bring actions for violations. If passed, Maui’s outright ban could still face enforcement and legal challenges – including state preemption and federal Commerce Clause challenges.

While this is a unique development, local efforts to protect against health and environmental concerns are nothing new, but they do not always remain confined to their original purpose. For example, California’s Safe Drinking Water and Toxic Enforcement Act of 1986, commonly known as Proposition 65, was originally passed to protect the state’s drinking water sources from being contaminated with chemicals known to cause cancer or reproductive harm. However, Proposition 65 does not act to ban the use of any chemicals; instead, it imposes warning requirements prior to consumer exposure to certain chemicals known to the state to cause cancer or reproductive harm. The 2012 listing of benzophenone to the state’s list of regulated chemicals has already caused many sunscreen manufacturers using octocrylene, another FDA-approved active ingredient that may contain small amounts of benzophenone, to reformulate or use a more purified form of the ingredient.

Conkle, Kremer & Engel has many years of experience representing clients in the beauty and skin care industry address challenging regulatory compliance issues. CK&E attorneys help clients stay out of legal crosshairs by working with them to ensure their products continue to meet all legal requirements, and helping them plan for foreseeable changes in the law.

California’s Office of Health Hazard Assessment (OEHHA) has issued new Proposition 65 Warning Regulations that will go into effect on August 30, 2018. It is important for companies to understand the changed regulations and be proactive in adapting their product labels and even internet marketing to adapt to the new regulations. The coming changes have introduced a variety of new concepts, imposing additional burdens on businesses selling their products in California, and making it easier for plaintiff Prop 65 attorneys and groups to bring costly private enforcement actions.

The OEHHA has made significant changes to the safe-harbor language requirements that govern the language, text, and format of such warnings. The new regulations introduce the concept of a “warning symbol,” which must be used on consumer products, though not on food products. The “warning symbol” must be printed in a size no smaller than the height of the word “WARNING,” and should be in black and yellow, but can be in black and white if the sign, label, or shelf tag for the product is not printed using the color yellow.

Warnings must now also specifically state at least one listed chemical found in the product and include a link to OEHHA’s new website www.P65Warnings.ca.gov. These are examples of the new format for more specific warnings:

For exposure to carcinogens: “ WARNING: This product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause cancer. For more information, go to www.P65Warnings.ca.gov.”

For exposure to reproductive toxins: “ WARNING: This product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause birth defects or other reproductive harm. For more information, go to www.P65Warnings.ca.gov.”

For exposure to both carcinogens and reproductive toxins: “ WARNING: This product can expose you to chemicals including [name of one or more listed chemicals], which is [are] known to the State of California to cause cancer, and [name of one or more chemicals], which is [are] known to the State of California to cause birth defects or other reproductive harm. For more information, go to www.P65Warnings.ca.gov.”

Certain special categories of products, such as food and alcoholic beverages, have a specialized URL that must be used. For example, warnings on food products must display the URL www.P65Warnings.ca.gov/food.

Recognizing that many consumer products have limited space “on-product” to fit the long-form warnings, the OEHHA has enacted new regulations allowing abbreviated “on-product” warnings. This short warning is permissible only if printed on the immediate container, box or wrapper of the consumer product. An example of the required format for the abbreviated warnings is:

“ WARNING: Cancer and Reproductive Harm – www.P65Warnings.ca.gov

The new regulations also specifically address internet sales for the first time. Warnings must be provided with a clearly marked hyperlink on the product display page, or otherwise prominently displayed to the purchaser before completion of the transaction. It will not be sufficient if the product sold on the internet bears the required label, but the internet point of purchase listing does not.

The particular requirements for each specific product can vary, so manufacturers and resellers are well-advised to seek qualified counsel to review their situation before committing to potentially costly label and website changes that may not comply with the new requirements. Conkle, Kremer & Engel attorneys stay up to date on important regulatory developments affecting their clients in the manufacturing and resale industries, and are ready to help clients navigate the changing regulatory landscape in California and elsewhere.

Although the new regulations take effect August 30, 2018, and the new warning labels are required for products manufactured after that date, companies can begin using the changed labels now. It is definitely not advisable to wait until August 2018 to begin making the required changes.

Conkle, Kremer & Engel attorney H. Kim Sim was on the featured panel of this year’s Legal & Regulatory Conference sponsored by the Personal Care Product Council. The featured panel, called “California: The Wild, Wild West,” explored the changes and challenges of the new business landscape in California, which boasts an economy that would place it sixth among the world’s nations. The panel discussion was held on May 10, 2017 at Hilton La Jolla Torrey Pines in San Diego, California. John Conkle, the CK&E attorney originally scheduled to speak on this panel, was unable to appear due to a federal court trial conflict.

John Conkle will attend the conference on behalf of CK&E to address current legal trends and developments in the cosmetic and personal care products industry. This annual event by the PCPC – the leading national trade association for the cosmetic and personal care products industry – is a must-attend for beauty companies across the country, with its unique focus on the many challenges that are on the horizon for the beauty industry. The presentation this year will include a particularly timely focus on international trade issues affecting the cosmetics industry, including appearances by industry representatives from Canada and Mexico.

This year’s conference is particularly topical panel discussion entitled “2016 Elections: What happened and what it means for you!” The panel included Dan Schnur, a leading political strategist and Director of Jesse Unruh Institute of Politics at University of Southern California, which runs the USC-Los Angeles Times Daybreak Poll that was one of the few polls to correctly predict Donald Trump’s election. In comments during their PCPC presentation, the panel noted that if President Trump follows through with pledges such as environmental regulation rollbacks, it is likely that California will respond by enacting its own additional rules and regulations.

Once again, Conkle, Kremer & Engel attorneys Mark Kremer and Kim Sim have been honored to participate in and contribute to the revolutionary Beauty Industry Market Access (BIMA) program, led by beauty industry guru Patty Schmucker of American Made Beauty. BIMA is a multi-day intensive domestic and international trade and business education program taught by leading health and beauty industry experts. BIMA participants focus on key principles essential to expand their personal care products businesses both in the U.S. and overseas.

Mark contributes to the BIMA educational program by teaching modules on domestic and foreign intellectual property protection and international distribution agreements. Participants are particularly advised about cost-effective methods of protecting their intellectual property internationally, such as international trademark registrations through the Madrid System, which can offer a centralized application process for trademark registration in over 90 countries based on a brand owner’s domestic application or registration. Kim adds her expertise in domestic regulatory compliance, including Prop 65, California Organic Products Act (COPA), Safe Cosmetics Act, California Air Resources Board (CARB) regulations and survey requirements, and federal and state Made in the USA regulations.

BIMA is sponsored by Universal Companies, which has been in the beauty industry for over 18 years and is an important distributor of more than 300 brands in the spa, salon, esthetics and massage market, as well as their own proprietary brands.

In partnership with the California Trade Alliance (CTA), access to international trade shows are available to companies that participate in the BIMA programs. BIMA participants can exhibit in the popular California Pavilion regularly sponsored by CTA at Cosmoprof Bologna and Cosmoprof Hong Kong, among the world’s largest and most important beauty industry trade shows.

On April 12, 2016, Conkle, Kremer & Engel attorney John Conkle flew to Sacramento to be part of Personal Care Products Council’s delegation for California Lobby Day. The Personal Care Products Council (PCPC) advocates for the personal care products, beauty and cosmetics industry at federal, state and local levels on legislative priorities and regulatory issues.

Conferences held in the Governor’s Council Room featured presentations by Nancy McFadden (Executive Secretary to Governor Edmund G. Brown), Graciela Castillo-Krings (Deputy Legislative Secretary to Governor Edmund G. Brown, Jr.), Dr. Meredith Williams (Deputy Director of Safer Products and Workplaces Program Director, Department of Toxics & Substance Control), and Elise Rothschild (Deputy Director of the Hazardous Waste Management Program, Department of Toxics & Substance Control). John joined teams of PCPC staff and member companies who met with legislative offices to discuss the economic impact of the industry and legislation pending before the California legislature. The day’s events were capped with a reception at which PCPC staff and members were joined by California State Legislators.

Conkle, Kremer & Engel is a proud and active member of the Personal Care Products Council. CK&E attorneys are glad to lend their legal expertise to the PCPC and its member companies by participating in PCPC conferences and industry advocacy efforts..

Conkle, Kremer & Engel attorney John Conkle is proud to have again been invited to join the Personal Care Products Council’s delegation for California Lobby Day, an annual PCPC event held at the Capitol in Sacramento, California. The Personal Care Products Council (PCPC) represents the personal care products, beauty and cosmetics industry at the federal, state and local level on issues of interest to the industry.

California Lobby Day represents a unique opportunity for industry leaders to meet with legislators including Leadership, key Committee Chairs and members of the Legislative Women’s Caucus, state officials, and their staff members and to engage in open discussions about legislative and regulatory issues affecting the personal care products industry. The day is expected to include briefings in the Governor’s Office by the executive department personnel and meetings with staff in the offices of members of the State Legislature, as well as a reception for members of the California Legislature, personnel from the Office of Governor Brown, and PCPC members and staff. Among those with whom John is expecting to meet are Nancy McFadden (Executive Secretary to Governor Brown); Carol Monahan-Cummings (Office of Environmental Health Hazard Assessment); Meredith Williams (Deputy Director of Safer Consumer Products and Workplaces Program, Department of Toxic Substances Control); and Panorea Advis (Director of the Governor’s Office of Business and Economic Development).

Conkle, Kremer & Engel is proud to be an active member of the Personal Care Products Council. Over the years, CK&E has provided legal expertise to the PCPC and its member companies by presenting at conferences organized by the PCPC on legal and regulatory matters, as well as representing many PCPC member companies. CK&E has also been a frequent sponsor of conferences organized by the PCPC and has participated in numerous events hosted by the PCPC.